uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk.
Enforcement
- Recall Number
- Z-2521-2020
- Event ID
- 85196
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- July 15, 2020
- Initiation Date
- February 27, 2020
- Classification Date
- July 6, 2020
- Termination Date
- May 28, 2021
- Address
- No. 2258 Chengbei Rd, Jiading Ind., Shanghai, N/A, China
Description
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk.
Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation.
Model Number uDR 596i with software versions R002.19.0-1.8402-690106 and R002.19.0.8648.690112. Serial numbers: 270012, 270013, 270014, 270015, 270016 and 270017. UDI numbers: (01)06971576833023(240)88000093(21)270012; (01)06971576833023(240)88000093(21)270013; (01)06971576833023(240)88000093(21)270014; (01)06971576833023(240)88000093(21)270015; XXX; and XXX.
US Nationwide distribution including in the state of Texas.
6 units